FDA UDI
In Commercial Distribution
🇺🇸 United States
Fast-Fix ECG Electrode
DI: 06430035220335
·
Model: 901155
·
Bittium Biosignals Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fast-Fix ECG Electrode
- Primary DI
- 06430035220335
- Version / Model
- 901155
- Company Name
- Bittium Biosignals Oy
- Labeler DUNS
- 369960000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-04
- Public Version
- 2
- Public Version Date
- 2021-03-04
- Public Version Status
- Update
- Public Device Record Key
- 79f8bd3f-54c4-46a3-8ce0-db3473872b86
Device Description
The Fast-Fix ECG Electrode is a user-friendly, single-use electrode meant to use with Faros ECG devices. The electrode is affixed to the patient's chest, and it transfers the hearts biosignal from the body to the Faros ECG device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRX | Electrode, Electrocardiograph | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35035 | Electrocardiographic electrode, single-use | A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035220335 | GS1 |
Customer Contacts
- Phone
- +358400541179
- [email protected]